Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Prolapse
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.
Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).
This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18 years or older
- •Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
- •New York Heart association classification ≥3 for cohort 3 and classification 1 or 2 for cohorts 1 and 2
- •Willing and able to provide signed written informed consent
- •No contra-indication for long-term monitoring (known allergy to adhesives)
Exclusion Criteria
- •Prior cardiac surgery, including previous mitral valve intervention
- •Prior endovascular mitral valve repair (MitraClip)
- •Previous catheter ablation of ventricular arrhythmias
- •Patients not in sinus rhythm
- •Patients on anti-arrhythmic drugs but betablockers
- •Known alternative arrhythmic substrate, for example previous myocardial infarction
- •Known allergy to adhesives
Outcomes
Primary Outcomes
Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
Time Frame: 14 days
Number of days with ≥ 1 nsVT, VT or VF episode
Number of days with high PVC-burden ≥5%
Time Frame: 14 days
Number of days with a PVC-burden ≥5%
Day-to-day variation in percentage PVC burden
Time Frame: 14 days
Day-to-day variation of the absolute number of PVC burden in percentage
Time to arrhythmic mitral valve prolapse detection
Time Frame: 14 days
The number of days to reach the detection of arrhythmic mitral valve prolapse, defined as a PVC burden ≥ 5%, nsVT, VT or VF
Secondary Outcomes
- Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI(14 days)
- Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI(14 days)
- Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography(14 days)
- Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography(14 days)